Molecular Diagnostics

News on lab-developed tests and emerging diagnostic technologies.

Some researchers believe that the use of microfluidics in the analysis of exosomes will help clinicians overcome the problem of heterogeneity in cancer cells.

Palmetto GBA issued final local coverage determination for the tissue-based, 31-gene expression test, which determines a patient’s risk for metastatic disease.  

The firm plans to conduct a prospective trial of a pan cancer assay and aims to bring another assay focused on colorectal cancer through FDA clearance.

The firm said that the assay uses vaginal or rectal swabs to identify Group B Streptococcus DNA in about an hour. It has filed for 510(k) clearance with the US FDA.

The test is designed to detect the presence or absence of the Zika virus in serum or plasma collected alongside urine from patients with suspected infection.